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FEATURED EDITORIAL

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CDMO Selection Beyond Capabilities And Price

Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.

GUEST COLUMNISTS

Why You Should Measure Comparability Debt Before Ever Starting A Study
When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.
What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

PHARMA OUTSOURCING WHITE PAPERS

Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives
Explore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.

Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs)
ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.
Phase-Appropriate Approaches To Manufacturing And Testing
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
Applications Of Liquid-Filled Capsules For Challenging APIs In Pharmaceutical Manufacturing
Discover the benefits of liquid-filled capsules for efficient, scalable, and patient-friendly drug manufacturing, and how they can enhance bioavailability and simplify complex formulations.
Practical Considerations For Your Process Characterization Study
Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.
What FDA CRLs Reveal About Method Validation
FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.